Report on the SCRA Nuts and Bolts Workshop II: case studies of citrus greening, Ultra-low Gossypol Cotton, and blight tolerant, low-acrylamide potato.

To be commercialized and grown in the US, genetically engineered (GE) crops typically go through an extensive food, feed, and environmental safety assessment process which, in certain instances, requires complex consultations with three different US regulatory agencies. Many small market, niche, and specialty crops have been genetically engineered using the modern tools of recombinant DNA but few have been commercialized due to real or perceived regulatory constraints. This workshop discussed the practical aspects of developing dossiers on GE specialty, niche, or small-market crops/products for submission to US regulatory agencies. This workshop focused on actual case studies, and provided an opportunity for public or private sector scientists and crop developers to spend time with regulatory officials to learn the specifics of compiling a dossier for regulatory approval. The objective of the workshop was to explain and demystify data requirements and regulatory dossier compilation by small companies, academics, and other developers.

The burden of disease and injury in the United States 1996.

BACKGROUND: Burden of disease studies have been implemented in many countries using the Disability-Adjusted Life Year (DALY) to assess major health problems. Important objectives of the study were to quantify intra-country differentials in health outcomes and to place the United States situation in the international context. METHODS: We applied methods developed for the Global Burden of Disease (GBD) to data specific to the United States to compute Disability-Adjusted Life Years. Estimates are provided by age and gender for the general population of the United States and for each of the four official race groups: White; Black; American Indian or Alaskan Native; and Asian or Pacific Islander. Several adjustments of GBD methods were made: the inclusion of race; a revised list of causes; and a revised algorithm to allocate cardiovascular disease garbage codes to ischaemic heart disease. We compared the results of this analysis to international estimates published by the World Health Organization for developed and developing regions of the world. RESULTS: In the mid-1990s the leading sources of premature death and disability in the United States, as measured by DALYs, were: cardiovascular conditions, breast and lung cancers, depression, osteoarthritis, diabetes mellitus, and alcohol use and abuse. In addition, motor vehicle-related injuries and the HIV epidemic exacted a substantial toll on the health status of the US population, particularly among racial minorities. The major sources of death and disability in these latter populations were more similar to patterns of burden in developing rather than developed countries. CONCLUSION: Estimating DALYs specifically for the United States provides a comprehensive assessment of health problems for this country compared to what is available using mortality data alone.